James Gianoutsos, Mba Email & Phone Number

Pittsburgh, PA, US

Pittsburgh, Pennsylvania, US

Rimsys is a world-leading Regulatory Information Management (RIM) software for medical technology companies that digitizes, automates, and creates regulatory order. The only holistic RIM software for medical devices, in-vitro diagnostics, and medical device software, Rimsys makes it easy to navigate the pillars of regulatory affairs, including product.

Medical Device Regulatory & Quality Consulting Services – Client-focused consulting services specially tailored to meet the needs of themedical device market and improve regulatory compliance, increase quality awareness, and expedite time-to-marketo Key Project #1: Philips Healthcare - Regulatory Project Lead responsible for operations, regulatory affairs.

Pittsburgh, PA, US

Carmell Therapeutics Corporation is a privately-owned biotechnology company focused on the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs). These PBMs contain a concentration of natural regenerative factors that promote healing, reduce complications, and lead to healthcare savings.-Establish the Quality Management.

Export, Pennsylvania, US

• Served as the Management Representative and managed all aspects of the Quality Management System (QMS)
• Responsible for worldwide regulatory strategy, international product registrations/renewals, and regulatory submissions
• Prepared and managed 510(k) submissions and technical file documentation
• Managed complaint handling, vigilance reporting, medical device reporting, and post-market surveillance activities
• Nurtured critical subcontractors into compliance with ISO13485, cGMP, and internal requirements
• Prepared and submitted FDA Q-Subs and formulated regulatory and submission response strategies

Raleigh, North Carolina, US

• Managed all aspects of the Quality Management System (QMS)
• Responsible for all quality-related decisions regarding the company’s only commercial product, TissuGlu® Surgical Adhesive
• Responsible for drafting the Sylys® Surgical Sealant Investigational Device Exemption (IDE) submission
• Directly supported the company during the FDA's Medical Device Advisory Committee for TissuGlu® Surgical Adhesive with respect to presentation preparation, analysis and review of clinical trial data, and strategy of.
• Established the Unique Device Identification (UDI) process for the company, including compliance with HIBC Labeling requirements, revision of all product labels, and submission of label information to the Global Unique.
• Responsible for preparing the company for US commercial distribution of its recently FDA approved product (TissuGlu® Surgical Adhesive) including vetting distribution partners, integrating the company’s quality system.

Raleigh, North Carolina, US

• Maintained the Quality Management System (QMS) for Class III Medical Devices (TissuGlu® Surgical Adhesive and Sylys® Surgical Sealant) including Complaint Handling, Vigilance Reporting, Corrective and Preventive.
• Successfully completed business process reengineering for Risk Management, CAPA, Supplier Management, Training, Complaint Handling, Vigilance Reporting, Medical Device Reporting, Equipment Control, Sampling Plans, and.
• Established new QMS processes in engineering change control, device master record (DMR) control, qualification of equipment, and sampling
• Drafted over 30% of the Pre-Market Approval (PMA) manufacturing module submission for TissuGlu® Surgical Adhesive
• Identified and mitigated regulatory risk by improving CAPA timeliness by 40%; verified by 100% on-time metrics over the last five (5) quarters
• Project lead tasked with preparing the company for FDA pre-approval inspection (PAI) within a three-month timeframe and successfully led the company through the FDA PAI with zero (0) observations

Amsterdam, Noord-Holland, NL

• Initiated and actively managed distribution and manufacturing recalls
• Drafted recall strategies for domestic and international products
• Managed the Corrective and Preventive Action (CAPA) system
• Performed Quality System and process audits including reporting, follow-up activities, and closure of nonconformities
• Initiated delivery holds, product retention, and product dispositions
• Led integration activities for a new complaint handling system (Trackwise) and a new instance of SAP (MP1)

Amsterdam, Noord-Holland, NL

• Managed the entire Complaint Handling System within the Philips Children’s Medical Ventures (ChMV) business unit to maintain compliance with FDA regulation Title 21 CFR Part 820 & 803
• Managed the chain of custody for products associated with adverse events
• Reviewed and processed ChMV quality complaints in a uniform and timely manner ensuring accuracy and completeness
• Drafted letters to customers, business institutions, and various regulatory agencies applying expertise of device performance and corresponding patient events
• Identified potential reportable adverse events to ensure timely decision-making and preparation of Medical Device Reports (MDR) to the FDA
• Implemented a Product Investigation Lab for Root Cause Analysis

Amsterdam, Noord-Holland, NL

• Supported four business segments and over 25 product lines with data analysis and reporting while meeting strict deadlines for the Home Healthcare Solutions business unit
• Developed and executed custom SAP reports to determine corrective action effectiveness and supported Medical Device Reporting (MDR), Health Hazard Evaluation (HHE) and Post Market Risk Assessment (PMRA) investigations
• Managed the quarterly Quality Management System Review presentation and led the monthly Quality Business Review (QBR) meetings with upper management
• Co-led a complaint trending project that developed, automated, and implemented trending and forecasting tools in support of a Closed Loop CAPA system while maintaining compliance within the existing Quality System
• Developed, documented, and implemented Microsoft Office SharePoint Server (MOSS) processes and procedures at a user-end for the Quality Systems department
• Developed the User Acceptance Testing (UAT) test scripts for validation of an internal SharePoint website

Amsterdam, Noord-Holland, NL

• Taught Six Sigma Green Belt training modules on Basic Statistics, Minitab, Stability, Statistical Process Control, Process Capability, and Root Cause Analysis (5 Why’s)
• Trained Project Managers and Design Quality Engineers in Minitab and Process Capability and helped develop test criteria for a Class II medical device
• Developed methods to analyze Cost of Quality (CoQ) as it relates to Respironics Sleep and Home Respiratory Group and reported costs to Executive Management

Amsterdam, Noord-Holland, NL

• Conducted an analysis of Cost of Quality (CoQ) related to internal failure costs for a global leader in the sleep and home respiratory market
• Developed a cost model to implement throughout products and facility to obtain non-quality costs on a weekly basis

Master Of Business Administration (M.B.A.), Operations Management And Strategy

Bachelor'S Degree, Operations Management